A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults

A Evaluate HRS5580 for Injection for Prevention of Postoperative Nausea and Vomiting Efficacy and Safety of Ⅱ Period, Randomized, Multicenter, Dose of Exploration, Positive Control, Placebo-controlled, Double-blind, Double Simulation Trials

The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.

Study Overview

• Status: Completed
• Conditions: Preventing of Postoperative Nausea and Vomiting in Adults
• Intervention / Treatment: Drug: Ondansetron; Drug: HRS5580; Drug: HRS5580; Drug: blank preparation

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Plan to undergo elective surgery under general anesthesia；
3. ≥18 years old
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification
6. Expected postoperative hospital stay ≥72 hours
7. PONV risk factors ≥3

Exclusion Criteria:

1. Subjects with vomiting and/or retching and nausea occurred before surgery
2. Subjects with a history of vestibular disease, central nervous system and other system diseases
3. Subjects with a previous history of chronic nausea or vomiting/retching
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Abnormal electrocardiogram
9. Abnormal values in the laboratory
10. Allergic to a drug ingredient or component
11. Received treatment with potential antiemetic effects before starting the investigational product
12. Subjects who received chemotherapy prior to surgery
13. Use of drugs that affect the antiemetic effect, and the time between the last use of the test drug and the start of the time is less than 5 half-lives
14. Plan to receive local anesthesia only or total intravenous anesthesia only
15. Subjects who are expected to require an in-situ nasogastric tube or orogastric tube after completion of surgery
16. Subjects expected to be transferred to the ICU at the end of surgery
17. Pregnant or nursing women
18. No birth control during the specified period of time
19. Participated in clinical trials of other drugs (received experimental drugs)
20. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS5580	Drug: HRS5580; HRS5580; low dose; Drug: HRS5580; HRS5580; middle dose
Experimental: Treatment group B: HRS5580	Drug: HRS5580; HRS5580; low dose; Drug: HRS5580; HRS5580; middle dose
Experimental: Treatment group C: HRS5580	Drug: HRS5580; HRS5580; low dose; Drug: HRS5580; HRS5580; middle dose
Active Comparator: Treatment group D: Ondansetron	Drug: Ondansetron; Ondansetron
Placebo Comparator: Treatment group E: blank preparation.	Drug: blank preparation; blank preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No vomiting rate within 72 hours after extubation	at 72 hours after extubation

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete response rate (defined as the proportion of subjects without vomiting and receiving no rescue therapy) at 24, 48, 72, 96, and 120 hours after extubation	at24, 48, 72, 96, and 120 hours after extubation
No vomiting at 24, 48, 96, and 120 hours after extubation,	at 24, 48, 96, and 120 hours after extubation
Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation	at 24, 48, 72, 96, and 120 hours after extubation
Proportion of participants not receiving rescue medication within 24, 48, 72, 96, and 120 hours of extubation	at 24, 48, 72, 96, and 120 hours of extubation

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): October 29, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Neurotransmitter Agents; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Ondansetron
• Other Study ID Numbers: HRS5580-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No